PHARMACY TECHNICIAN TEST FINAL EXAM 2
VERSIONS (VERSION A AND B) ACTUAL EXAM
QUESTIONS WITH DETAILED VERIFIED ANSWERS
(100% CORRECT ANSWERS) /ALREADY GRADED A+
Food and Drug Administration (FDA) - ANSWER Approves new drug entities
Regulates package inserts
Issues recalls of affected medicinal products
Drug Enforcement Agency (DEA) - ANSWER places drug products into "schedules"
based on the drug's potential for abuse
State Board of Pharmacy (BOP) - ANSWER Each state's regulatory and licensing
agency for policing the practice of pharmacy
Administrative Code - ANSWER lists the penalties for violations of pharmacy law
Pharmacy Practice Act - ANSWER Sets forth rules and definitions involved in the
practice of pharmacy
State Controlled Substance Act - ANSWER Explains what drug entities the State has
designated as it's own controlled substances
The state can always ________ the level of control over federal laws but they can never
_______ it. - ANSWER increase, decrease
Centers for Medicare and Medicaid Services (CMS) - ANSWER Governmental entity
that provides coverage for over 100 million people in its oversight of the Medicare,
Medicaid and Children's Hospital Insurance program
National Association of Boards of Pharmacy (NABP) - ANSWER Research, develop,
and help implement better ways of regulating the practice of pharmacy
Federal Food and Drug Act (1906) - ANSWER (1st) to demand purity of products and
provide scientific evidence for the claims made on products
Federal Food, Drug, and Cosmetic Act (FFDCA) (1938) - ANSWER 1. Clarifies and
expands what is constituted as misbranding and adulteration.
2. (1st) to demand safety of the drug for the use of which it is marketed
Replaced the 1906 Federal Food and Drug Act
,The Durham-Humphrey Amendment (1951) - ANSWER Required printed instructions
for drug use on the manufacturer's label.
Created the class known as legend drugs/ prescription drugs
The Kefauver-Harris Amendment (1962) - ANSWER Required proof of effectiveness
and regulated drug advertisement
Poison Prevention Packaging Act (PPPA) (1970) - ANSWER Decrease accidental
poisonings from Rx medications.
Requires caps on Rx's
Drug Listing Act (1972) - ANSWER Require all drug establishments register their
establishment with the FDA.
Data presented to the FDA: name, dosage, route of administration, ingredients,
packaging, and NDC
The Medical Device Amendment (1976) - ANSWER Requires manufacturers to get pre-
market approval from the FDA for certain medical devices
Prescription Drug Marketing Act (1987) - ANSWER Ensures that drug products
available for purchase were safe and effective and to avoid risk of reimporting drugs
from countries other then the US
Monitors drug travel
History of travel= a drug's pedigree
Omnibus Budget Reconciliation Act (OBRA) (1990) - ANSWER Saves taxpayers money
through more efficient use of taxpayer dollars used to fund prescriptions
Dietary Supplement Health And Education Act (DSHEA) (1994) - ANSWER Established
standards for dietary supplements
Made standardized labeling and proof of safety mandatory
Health Insurance Portability and Accountability Act (HIPAA) (1996) - ANSWER Patient
privacy
Created a new identifying number (NPI) for healthcare entities
FDA Modernization Act (1997) - ANSWER Made changes to streamline the drug
approval process, regulate drug compounding in pharmacies, regulate medical devices,
and research mercury containing products
"Rx" symbol on bottles
Medicare Prescription Drug, Improvement, and Modernization Act (MMA) (2003) -
ANSWER Introduction of an entitlement for prescription drugs for Medicare recipients
Provided for the creation of Medicare Advantage health care plans and Health Savings
Accounts
,Medicaid Tamper-Resistant Prescription Act (2008) - ANSWER Requires any
prescription written for Medicaid coverage individual be written on a tamper resistant
prescription blank.
Patient Protection and Affordable Care Act (PPACA) (2010) - ANSWER "Obamacare"
Intended to lower the cost of health care by increasing the quality and affordability of
health care plans in both the public and private system
Created insurance exchanges, insurance mandates, and subsidies intended to help pay
for coverage
Inclusion of ind. with pre-existing conditions at the same rate as more healthy ind.
Drug Quality and Security Act (DQSA) (2013) - ANSWER Regulates large compounding
facilities that are defined as "outsourcing facilities"
Drug Supply Chain Security Act (DSCSA) (2013) - ANSWER Title II of DSQA
Create an electronic system to identify and trace certain prescription drugs as they
travel across the country.
Track each product from its creation, through each step of the distribution process, and
into the end user's hands
The Harrison Narcotic Act (1916) - ANSWER Control illegal narcotic trafficking
Employed "tax stamps" on legal narcotics
The Drug Abuse Control Amendment (DACA) (1965) - ANSWER Expands the Harrison
Narcotic Act to include barbiturates and stimulant drugs
No more "tax stamps"
The Bureau of Narcotics and Dangerous Drugs (1968) - ANSWER Combination of the
Harrison Act and DACA
Renamed DEA
The Comprehensive Drug Abuse Prevention And Control Act (CSA) (1970) - ANSWER
"Controlled Substances Act"
Record keeping and registration requirements of sufficient detail to be able to track
transactions between manufacturers, suppliers, practitioners, and consumers
replaced Harrison and DACA
Anabolic Steroid Control Act (1990) - ANSWER Listed anabolic steroids as Schedule 3
controlled substances
Added pro-hormones as controlled substances (2004)
Combat Methamphetamine Epidemic Act (CMEA) (2005) - ANSWER Provides minimum
requirements covering listed products "Scheduled Listed Chemical Products" (SLCP)
Requirements:
SLCP stored behind the pharmacy counter or in a locked cabinet
All employees must have specialized training
, Retail sellers must verify the identity of the purchaser
Retail sellers must maintain a log of each sale; purchaser, signature, product, quantity,
date and time
Log book must be maintained for 2 years
Limits amount of SLCPs per purchase and per month
The Ryan Haight Online Pharmacy Consumer Protection Act (2008) - ANSWER Ability
for the DEA to take action against unapproved internet pharmacies
Standard of Practice - ANSWER What would the typical practitioner, armed with
knowledge typical of the profession, do in response to the situation at hand?
Joint Commission - ANSWER (firmly known as JCAHO)
Non-governmental organization which conducts voluntary certification inspections on
nearly 20,000 health care organizations and programs
Chart reviews, equipment reviews, proper storage, security, stock floor, and medicine
chart inspections.
Institute for Safe Medication Practices (ISMP) - ANSWER non-profit organization
dedicated to educate the health care community and consumers about preventing
medication errors from labeling, packaging, prescribing, dispensing, and
communications.
Formed a partnership with the FDA to reduce preventable errors
Third Party Audits - ANSWER Checks and balances from third party payers.
Verification that the claims submitted and paid were correct and reasonable
The auditor reports to the payer and asks for reimbursement and punishment
Employer Audits - ANSWER Outlines responsibilities and duties of each member of the
pharmacy team
Outline what the employer feels is good and acceptable business practices; "mission
statement"; Policy and Procedure Manual
Who regulate the pharmacy area and it's equipment? - ANSWER Both governmental
and non-governmental agencies
FDA, State Board of Pharmacy, Joint Commission, etc.
Requirements for pharmacy area - ANSWER Location, size, Americans with Disabilities
Act, environment, storage, clean/sterile, hazard and waste disposal, security, reference
materials and record books, proper equipment, and proper licensing and registrations
NDA - ANSWER New Drug Application
Clinical trials of the NDA process are broken down into four phases
12-16 years
VERSIONS (VERSION A AND B) ACTUAL EXAM
QUESTIONS WITH DETAILED VERIFIED ANSWERS
(100% CORRECT ANSWERS) /ALREADY GRADED A+
Food and Drug Administration (FDA) - ANSWER Approves new drug entities
Regulates package inserts
Issues recalls of affected medicinal products
Drug Enforcement Agency (DEA) - ANSWER places drug products into "schedules"
based on the drug's potential for abuse
State Board of Pharmacy (BOP) - ANSWER Each state's regulatory and licensing
agency for policing the practice of pharmacy
Administrative Code - ANSWER lists the penalties for violations of pharmacy law
Pharmacy Practice Act - ANSWER Sets forth rules and definitions involved in the
practice of pharmacy
State Controlled Substance Act - ANSWER Explains what drug entities the State has
designated as it's own controlled substances
The state can always ________ the level of control over federal laws but they can never
_______ it. - ANSWER increase, decrease
Centers for Medicare and Medicaid Services (CMS) - ANSWER Governmental entity
that provides coverage for over 100 million people in its oversight of the Medicare,
Medicaid and Children's Hospital Insurance program
National Association of Boards of Pharmacy (NABP) - ANSWER Research, develop,
and help implement better ways of regulating the practice of pharmacy
Federal Food and Drug Act (1906) - ANSWER (1st) to demand purity of products and
provide scientific evidence for the claims made on products
Federal Food, Drug, and Cosmetic Act (FFDCA) (1938) - ANSWER 1. Clarifies and
expands what is constituted as misbranding and adulteration.
2. (1st) to demand safety of the drug for the use of which it is marketed
Replaced the 1906 Federal Food and Drug Act
,The Durham-Humphrey Amendment (1951) - ANSWER Required printed instructions
for drug use on the manufacturer's label.
Created the class known as legend drugs/ prescription drugs
The Kefauver-Harris Amendment (1962) - ANSWER Required proof of effectiveness
and regulated drug advertisement
Poison Prevention Packaging Act (PPPA) (1970) - ANSWER Decrease accidental
poisonings from Rx medications.
Requires caps on Rx's
Drug Listing Act (1972) - ANSWER Require all drug establishments register their
establishment with the FDA.
Data presented to the FDA: name, dosage, route of administration, ingredients,
packaging, and NDC
The Medical Device Amendment (1976) - ANSWER Requires manufacturers to get pre-
market approval from the FDA for certain medical devices
Prescription Drug Marketing Act (1987) - ANSWER Ensures that drug products
available for purchase were safe and effective and to avoid risk of reimporting drugs
from countries other then the US
Monitors drug travel
History of travel= a drug's pedigree
Omnibus Budget Reconciliation Act (OBRA) (1990) - ANSWER Saves taxpayers money
through more efficient use of taxpayer dollars used to fund prescriptions
Dietary Supplement Health And Education Act (DSHEA) (1994) - ANSWER Established
standards for dietary supplements
Made standardized labeling and proof of safety mandatory
Health Insurance Portability and Accountability Act (HIPAA) (1996) - ANSWER Patient
privacy
Created a new identifying number (NPI) for healthcare entities
FDA Modernization Act (1997) - ANSWER Made changes to streamline the drug
approval process, regulate drug compounding in pharmacies, regulate medical devices,
and research mercury containing products
"Rx" symbol on bottles
Medicare Prescription Drug, Improvement, and Modernization Act (MMA) (2003) -
ANSWER Introduction of an entitlement for prescription drugs for Medicare recipients
Provided for the creation of Medicare Advantage health care plans and Health Savings
Accounts
,Medicaid Tamper-Resistant Prescription Act (2008) - ANSWER Requires any
prescription written for Medicaid coverage individual be written on a tamper resistant
prescription blank.
Patient Protection and Affordable Care Act (PPACA) (2010) - ANSWER "Obamacare"
Intended to lower the cost of health care by increasing the quality and affordability of
health care plans in both the public and private system
Created insurance exchanges, insurance mandates, and subsidies intended to help pay
for coverage
Inclusion of ind. with pre-existing conditions at the same rate as more healthy ind.
Drug Quality and Security Act (DQSA) (2013) - ANSWER Regulates large compounding
facilities that are defined as "outsourcing facilities"
Drug Supply Chain Security Act (DSCSA) (2013) - ANSWER Title II of DSQA
Create an electronic system to identify and trace certain prescription drugs as they
travel across the country.
Track each product from its creation, through each step of the distribution process, and
into the end user's hands
The Harrison Narcotic Act (1916) - ANSWER Control illegal narcotic trafficking
Employed "tax stamps" on legal narcotics
The Drug Abuse Control Amendment (DACA) (1965) - ANSWER Expands the Harrison
Narcotic Act to include barbiturates and stimulant drugs
No more "tax stamps"
The Bureau of Narcotics and Dangerous Drugs (1968) - ANSWER Combination of the
Harrison Act and DACA
Renamed DEA
The Comprehensive Drug Abuse Prevention And Control Act (CSA) (1970) - ANSWER
"Controlled Substances Act"
Record keeping and registration requirements of sufficient detail to be able to track
transactions between manufacturers, suppliers, practitioners, and consumers
replaced Harrison and DACA
Anabolic Steroid Control Act (1990) - ANSWER Listed anabolic steroids as Schedule 3
controlled substances
Added pro-hormones as controlled substances (2004)
Combat Methamphetamine Epidemic Act (CMEA) (2005) - ANSWER Provides minimum
requirements covering listed products "Scheduled Listed Chemical Products" (SLCP)
Requirements:
SLCP stored behind the pharmacy counter or in a locked cabinet
All employees must have specialized training
, Retail sellers must verify the identity of the purchaser
Retail sellers must maintain a log of each sale; purchaser, signature, product, quantity,
date and time
Log book must be maintained for 2 years
Limits amount of SLCPs per purchase and per month
The Ryan Haight Online Pharmacy Consumer Protection Act (2008) - ANSWER Ability
for the DEA to take action against unapproved internet pharmacies
Standard of Practice - ANSWER What would the typical practitioner, armed with
knowledge typical of the profession, do in response to the situation at hand?
Joint Commission - ANSWER (firmly known as JCAHO)
Non-governmental organization which conducts voluntary certification inspections on
nearly 20,000 health care organizations and programs
Chart reviews, equipment reviews, proper storage, security, stock floor, and medicine
chart inspections.
Institute for Safe Medication Practices (ISMP) - ANSWER non-profit organization
dedicated to educate the health care community and consumers about preventing
medication errors from labeling, packaging, prescribing, dispensing, and
communications.
Formed a partnership with the FDA to reduce preventable errors
Third Party Audits - ANSWER Checks and balances from third party payers.
Verification that the claims submitted and paid were correct and reasonable
The auditor reports to the payer and asks for reimbursement and punishment
Employer Audits - ANSWER Outlines responsibilities and duties of each member of the
pharmacy team
Outline what the employer feels is good and acceptable business practices; "mission
statement"; Policy and Procedure Manual
Who regulate the pharmacy area and it's equipment? - ANSWER Both governmental
and non-governmental agencies
FDA, State Board of Pharmacy, Joint Commission, etc.
Requirements for pharmacy area - ANSWER Location, size, Americans with Disabilities
Act, environment, storage, clean/sterile, hazard and waste disposal, security, reference
materials and record books, proper equipment, and proper licensing and registrations
NDA - ANSWER New Drug Application
Clinical trials of the NDA process are broken down into four phases
12-16 years
